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510(k) Data Aggregation

    K Number
    K213386
    Device Name
    Titan Manufacturing Bipolar Forceps
    Date Cleared
    2021-10-25

    (12 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Titan Manufacturing, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
    Device Description
    Titan Manufacturing Bipolar Forcep is a generic electrosurgical device (handpiece)/active accessory that is to be connected through a bipolar cable with the bipolar output of a standard, general electrosurgical generator unit (ESU) and footswitch. The bipolar cable, ESU and footswitch are not part of the subject device, therefore not included in this submission. The subject device is not an electrosurgical vessel sealer system. Titan Manufacturing Bipolar Forceps are indicated for use in general surgical procedures; designed to grasp, manipulate, and coagulate selected tissue. Titan Manufacturing Bipolar Forceps are to be connected through a suitable bipolar cable [not supplied by Titan Manufacturing, Inc.] with the bipolar output of a standard, general electrosurgical generator [not supplied by Titan Manufacturing, Inc.]. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch [not supplied by Titan Manufacturing, Inc.]. Titan Manufacturing, Inc., offers an extensive line of precision crafted reusable stainless steel and titanium bipolar forceps in a multitude of handle styles, lengths, and tip sizes. Titan Manufacturing Bipolar Forceps are available in styles such as but not limited to straight and bayonet styles, patterned designs such as but not limited to Semkin, Jewelers, Adson, Scoville-Greenwood, Ti Square Grip, Yargasil, Tenzel, McPherson, and Cozean, etc. Titan Manufacturing offers bipolar forceps in lengths from approximately 3 ½ inches to 10 ¾ inches ; titanium or stainless steel; insulated or non-insulated; irrigating or non-irrigating; straight, curved, angled or coaptation; and varying tip sizes from 0.2mm to 2.0mm. The product line is similar to those offered by other wellestablished bipolar forcep manufacturers [e.g., Codman, Kirwin, Faulhaber Pinzetten, Synergetics (a.k.a. Stryker), etc.]. Titan Manufacturing Bipolar Forceps are reusable medical devices, provided non-sterile and must be cleaned and sterilized prior to use. They are used with the bipolar output for standard, general electrosurgical generators (ESU). The Titan Manufacturing Bipolar Forceps are compatible with general electrosurgical generators with 4mm outlets; U.S. 2-pin plugs. Bipolar cables, ESU and footswitch are not part of the subject device. Titan Manufacturing Bipolar Forceps are available in four (4) general model types in stainless steel or titanium: Non-insulated; Insulated; Non-insulated/Irrigating; and Insulated/Irrigating.
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